Hybio Pharmaceutical Co., Ltd.
Form 483 issued June 26, 2015 · Shenzhen, China
- Investigator
- Lig Duu
- Observations
- 4
- Pages
- 3
- FEI number
- 3010165930
In short: On June 26, 2015, FDA issued a Form 483 with 4 observations to Hybio Pharmaceutical Co., Ltd. in Shenzhen, China (FEI 3010165930). The investigator was Lig Duu. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Air is recirculated to production areas, without adequate measures to…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for…
This inspection in context
Lig Duu
1 document · 2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmHybio Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hybio Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Hybio Pharmaceutical Co., Ltd.?
Lig Duu is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hybio Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated June 26, 2015.
How do I get the full Form 483 for Hybio Pharmaceutical Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.